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Review Pathway
Alvotech has followed its European filing for a biosimilar to Regeneron’s Eylea (aflibercept) 2mg with acceptance for review from the US Food and Drug Administration for its AVT06 candidate.
A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.
Doxecitine/doxribtimine, UCB’s investigational orphan drug for pediatric and adult patients with thymidine kinase 2 deficiency, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
The EU-level joint clinical assessments that will be introduced under the Health Technology Assessment Regulation from January 2025 represent a huge shift for drug companies launching products in the EU. Industry experts Alexander Natz and Matias Olsen offer key advice to help companies prepare for what is to come.
A total of 141 products have made it onto the European Medicines Agency’s PRIME (priority medicines) scheme since 2016 and over 370 applications have been denied entry.
A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.
Elinzanetant, Bayer’s investigational treatment for hot flashes in menopausal women, is among the latest drugs that have been filed for review by the European Medicines Agency for potential EU marketing approval.
Advanz Pharma, the company that markets Ocaliva for primary biliary cholangitis in the EU, will continue to supply the drug on a compassionate use or named patient basis.
Sanofi’s rilzabrutinib and Alvotech/Advanz Pharma’s golimumab (AVT05) are among five new entries on the European Medicines Agency’s latest monthly list of products for which marketing applications are currently under review. Both drugs are investigational and are yet to be approved anywhere in the world.
The EU-level joint clinical assessments that will be introduced under the Health Technology Assessment Regulation from January 2025 represent a huge shift for drug companies launching products in the EU. Industry experts Alexander Natz and Matias Olsen offer key advice to help companies prepare for what is to come.